DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
Response to Arguments
The amendments to claims 1, 27, and 37 are acknowledged and the previous 112(b) rejections are withdrawn.
Applicant’s arguments with respect to claim(s) 1, 27, and 33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. However, upon further consideration, a new ground(s) of rejection is made over Keating et al. (US 20210402157) in view of Herbert et al. (US 20080065012) and Chhabra et al. (US 20060079923) for claims 1 and 27 and Keating et al. (US 20210402157) in view of Herbert et al. (US 20080065012), Chhabra et al. (US 20060079923), and Hesselbjerg (US 20180071483) for claim 33.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“expandable mechanism” in claim 1. The limitation describing the expandable mechanism (“expandable mechanism disposed at a second distal portion of the second catheter”) fails to include sufficient structure to perform the recited function of "expanding". The specification describes “an expandable distal mechanism 403 that has tines 405 or similar elements designed to be expanded and moved back and forth through the clot 419 to mechanically break up and disengage the clot 419 from the vessel walls” in para. 0061. Therefore, the expandable mechanism is interpreted as a mechanism comprising expandable tine or any structural equivalent thereof that is expandable and disposed at the second distal portion of the second catheter.
“a second delivery means” and “expandable means” in claim 33. The limitation describing the first delivery means in claim 33 (“a second proximal end, a second distal end, and an outer diameter less than an inner diameter of the first lumen of the first delivery means, an expandable means disposed at a second distal portion of the second delivery means”) fails to include sufficient structure to perform the recited function of "delivery" and “expandable”. The specification fails to refer to the term “a second delivery means” or “expandable means”, but describes a balloon catheter comprising a distal balloon (para. 0042: “a balloon catheter 100 that is advanceable and retractable through a sheath 102…The balloon catheter 100 further includes a distal balloon 103”). Therefore, the second delivery means and expandable means are interpreted as the balloon catheter comprising the distal balloon above or any structural equivalent thereof.
“a proximal inflation means” in claim 33. The limitation describing the first delivery means in claim 33 (“a proximal inflation means disposed at a first distal portion of the first delivery means”) fails to include sufficient structure to perform the recited function of "inflation". The specification fails to refer to the term “a proximal inflation means”, but describes a sheath comprising a proximal balloon (para. 0043: “The sheath 102 has a distal end around which is placed a proximal balloon 111.”). Therefore, the proximal inflation means is interpreted as the proximal balloon above or any structural equivalent thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 22, 27-28, and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert] and Chhabra et al. (US 20060079923) [hereinafter Chhabra].
Regarding claim 1, Keating discloses a system 100 for removing a clot from a vessel (Fig. 1, para. 0041) comprising:
a first catheter 105 having a first proximal end (not shown), a first distal end 111 (Fig. 1, para. 0041), and a first lumen 117 therebetween (Fig. 1, para. 0041);
a proximal balloon 113 disposed at a first distal portion of the first catheter 105 (Fig. 1, para. 0041);
a second catheter 121 having a second proximal end (not shown), a second distal end 107 (Fig. 1, para. 0041), and an outer diameter less than an inner diameter of the first lumen 117 of the first catheter 105 (best shown in Fig. 1, para. 0041: “The balloon guide catheter 105 can further include the device delivery lumen 117 that extends through the balloon guide catheter 105 and that can be sized to allow the inner tube 121 to slide therethrough”);
an expandable mechanism (interpreted as distal occlusion element 109) disposed at a second distal portion of the second catheter 121 (Fig. 1, para. 0042);
a plaque displacement apparatus 123 comprising a removal catheter 126.
Keating further discloses that the plaque displacement apparatus 123 comprises expandable tines (see Fig. 1) and is used to cut against and fragment plaque (see Figs. 2D-E, para. 0048), wherein in a clot retention configuration, the plaque displacement apparatus 123 is distal to the proximal balloon 113 (see Figs. 2D-E) and wherein, in a clot removal configuration, the plaque displacement apparatus 123 is proximal to the proximal balloon 113 (Fig. 2I, para. 0056).
However, Keating fails to disclose a clot retention mechanism that utilizes an adhesive to fracture plaque in a vessel.
Herbert in the same field of endeavor teaches a clot retrieval device comprising a clot retention mechanism (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073), wherein, in an expanded configuration (Figs. 1E-F), the balloon is expanded to engage with a clot (Figs. 1E-F, para. 0076), wherein, in a clot retention configuration, the balloon is distal to a catheter 10 and the clot is secured to balloon with an adhesive 243 disposed on an outer surface of the balloon (Figs. 1D-F, para. 0076), and wherein, in a clot removal configuration, the balloon is withdrawn and the clot is secured to the balloon with the adhesive (para. 0076).
The substitution of one known clot removal device (the clot retention mechanism comprising the removal catheter and adhesive coated balloon as shown in Herbert) for another (the plaque displacement apparatus as shown in Keating) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the clot retention mechanism shown in Herbert would have yielded predictable results, namely, a way to engage and loosen clot material in its expanded state while also capturing the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert) which is beneficial to the intended purpose of Keatings device (para. 0040 of Keating: “Some examples presented herein can be used to isolate a lesion during plaque displacement such that plaque located on a blood vessel wall can be displaced and removed from the vasculature while inhibit dislodged plaque fragments from migrating from the treatment site”); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).However, modified Keating fails to disclose the removal catheter having at least one port and a semi-permeable membrane positioned around the at least one port, wherein the semi-permeable membrane comprises a plurality of openings, wherein the plurality of openings substantially surround a surface of the semi-permeable membrane; and wherein, in an expanded configuration, the adhesive is introduced through the at least one port and at least a portion of the adhesive permeates the semi-permeable membrane to engage with the clot;
Chhabra in the same field of endeavor of balloon catheters teaches that it is known in the art for balloon catheters to deliver adhesive through a lumen of the catheter and out of micropores of the balloon (para. 0019: “wherein the balloon is in fluid communication with at least one lumen defined within the catheter, wherein the balloon comprises a plurality of micropores, wherein the micropores in the balloon allow expression of an adhesive fluid at a defined pressure from the inside to the outside of the balloon). The balloon catheter comprises at least one port 2 and a semi-permeable membrane 1 positioned around the at least one port 2 (Fig. 1, para. 0070: “FIG. 1 illustrates a balloon (1), side holes (2) in the catheter walls for extruding and expressing a sealing adhesive fluid material into the lumen of the balloon”), wherein the semi-permeable membrane 1 comprises a plurality of openings 7 (Fig. 3, para. 0076), wherein the plurality of openings 7 substantially surround a surface of the semi-permeable membrane (para. 0067: “The pores may be disposed over the entire surface of the balloon (about 100% coverage”); and wherein, in an expanded configuration, the adhesive is introduced through the at least one port and at least a portion of the adhesive permeates the semi-permeable membrane to engage with a target site (see citation of para. 0070 above; para. 0046: “the balloon may be inflated with a bio-adhesive fluid”).
Accordingly, injecting adhesive through pores is a known alternative to coat the balloon with the adhesive for adhesive delivery. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive coated balloon and removal catheter in modified Keating to include the micropores, thereby forming the semi-permeable membrane and at least one port, respectively, as taught by Chhabra since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the semi-permeable membrane used in Chhabra would also deliver the adhesive to the target site (para. 0070 of Chhabra); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination of modified Keating in view of Chhabra would result in a product wherein, in a clot retention configuration, the semi-permeable membrane of Chhabra (Fig. 1, para. 0070: “FIG. 1 illustrates a balloon (1), side holes (2) in the catheter walls for extruding and expressing a sealing adhesive fluid material into the lumen of the balloon”) is secured to the clot with the adhesive (as taught by Herbert; Figs. 1E-G, para. 0076 of Herbert); and wherein, in a clot removal configuration, the clot is secured to the semi-permeable membrane with the adhesive (as taught by Herbert; para. 0076 of Herbert).
Regarding claim 22, modified Keating discloses wherein the second catheter 121A comprises a pointed distal tip (see Fig. 1 of Keating).
Regarding claim 37, modified Keating discloses wherein the at least one port 2 is comprised of a plurality of ports (see Fig. 1 of Chhabra), each of the plurality of ports 2 being positioned on multiple sides of the removal catheter (Fig. 1, para. 0070 of Chhabra: “side holes (2) in the catheter walls”).
Regarding claim 38, modified Keating discloses a plurality of lumens (Fig. 1, para. 0070 of Chhabra: “a double lumen catheter (4)”), each of the plurality of lumens being in fluid communication with at least one of the plurality of ports 2 (see Fig. 1 of Chhabra).
Regarding claim 39, modified Keating discloses wherein an exterior surface of the semi-permeable membrane is free of the adhesive prior to introduction of the adhesive through the port (para. 0185 of Chhabra).
Regarding claim 40, modified Keating discloses wherein the adhesive is introduced into an interior of the semi-permeable membrane and exits the semi-permeable membrane via the plurality of openings (para. 0048 of Chhabra: “, the sealing adhesive fluid material, is injected into the catheter and is chased with saline up into the balloon using a syringe equipped with a pressure gauge. The balloon is positioned against the aneurysm wall and cyanoacrylate is forced out of the pores”).
Regarding claim 41, modified Keating discloses wherein the adhesive binds the clot to the mesh membrane such that the clot is retained on the mesh membrane during withdrawal of the removal catheter from the vessel (Fig. 1F-G, para. 0076 of Herbert).
Regarding claim 27, Keating discloses a system 100 for removing a clot from a vessel (Fig. 1, para. 0041) comprising:
a first catheter 105 having a proximal end (not shown), a distal end 111 (Fig. 1, para. 0041), and at least one lumen 117 therebetween (Fig. 1, para. 0041);
a proximal balloon 113 disposed at a distal portion of the first catheter 105 (Fig. 1, para. 0041);
a second catheter 121 having a proximal end (not shown), a distal end 107 (Fig. 1, para. 0041), and an outer diameter less than an inner diameter of the at least one lumen 117 of the first catheter 105 (best shown in Fig. 1, para. 0041: “The balloon guide catheter 105 can further include the device delivery lumen 117 that extends through the balloon guide catheter 105 and that can be sized to allow the inner tube 121 to slide therethrough”);
an expandable mechanism (interpreted as distal occlusion element 109) disposed at a distal region of the second catheter 121 (Fig. 1, para. 0042);
plaque displacement apparatus 123 comprising a removal catheter 126.
Keating further discloses that the plaque displacement apparatus 123 comprises expandable tines (see Fig. 1) and is used to cut against and fragment plaque (see Figs. 2D-E, para. 0048).
However, Keating fails to disclose a clot retention mechanism that utilizes an adhesive to fracture plaque in a vessel.
Herbert in the same field of endeavor teaches a clot retrieval device comprising a clot retention mechanism (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073), wherein, in an expanded configuration (Figs. 1E-F), the balloon is expanded to engage with a clot (Figs. 1E-F, para. 0076), wherein, in a clot retention configuration, the balloon is distal to a catheter 10 and the clot is secured to balloon with an adhesive 243 disposed on an outer surface of the balloon (Figs. 1D-F, para. 0076), and wherein, in a clot removal configuration, the balloon is withdrawn and the clot is secured to the balloon with the adhesive (para. 0076).
The substitution of one known clot removal device (the clot retention mechanism comprising the removal catheter and adhesive coated balloon as shown in Herbert) for another (the plaque displacement apparatus as shown in Keating) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the clot retention mechanism shown in Herbert would have yielded predictable results, namely, a way to engage and loosen clot material in its expanded state while also capturing the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert) which is beneficial to the intended purpose of Keatings device (para. 0040 of Keating: “Some examples presented herein can be used to isolate a lesion during plaque displacement such that plaque located on a blood vessel wall can be displaced and removed from the vasculature while inhibit dislodged plaque fragments from migrating from the treatment site”); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).However, modified Keating fails to disclose the removal catheter including a first port and a mesh membrane positioned around the first port, wherein the mesh membrane comprises a plurality of pores substantially covering a surface of the mesh membrane; and wherein the adhesive both (1) expands the mesh membrane, and (2) permeates through the mesh membrane;
Chhabra in the same field of endeavor of balloon catheters teaches that it is known in the art for balloon catheters to deliver adhesive through a lumen of the catheter and out of micropores of the balloon (para. 0019: “wherein the balloon is in fluid communication with at least one lumen defined within the catheter, wherein the balloon comprises a plurality of micropores, wherein the micropores in the balloon allow expression of an adhesive fluid at a defined pressure from the inside to the outside of the balloon). The balloon catheter comprises a first port 2 and mesh membrane 1 positioned around the first port 2 (Fig. 1, para. 0070: “FIG. 1 illustrates a balloon (1), side holes (2) in the catheter walls for extruding and expressing a sealing adhesive fluid material into the lumen of the balloon”), wherein the mesh membrane 1 comprises a plurality of pores 7 (Fig. 3, para. 0076) substantially surround a surface of the semi-permeable membrane (para. 0067: “The pores may be disposed over the entire surface of the balloon (about 100% coverage”); and wherein the adhesive both (1) expands the mesh membrane (para. 0046: “the balloon may be inflated with a bio-adhesive fluid”), and (2) permeates through the mesh membrane to contact a target site (see citation of para. 0019 above).
Accordingly, injecting adhesive through pores is a known alternative to coat the balloon with the adhesive for adhesive delivery. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive coated balloon and removal catheter in modified Keating to include the micropores, thereby forming the mesh membrane and first port, respectively, as taught by Chhabra since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the mesh membrane used in Chhabra would also deliver the adhesive to the target site (para. 0070 of Chhabra); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination of modified Keating in view of Chhabra would result in a product wherein, in the clot retention configuration, the adhesive is introduced into the mesh membrane through the first port such that the adhesive to both (1) expand the mesh membrane (as taught by Chhabra; para. 0046 of Chhabra: “the balloon may be inflated with a bio-adhesive fluid”) and (2) permeates through the mesh membrane (as taught by Chhabra; para. 0019: “wherein the balloon is in fluid communication with at least one lumen defined within the catheter, wherein the balloon comprises a plurality of micropores, wherein the micropores in the balloon allow expression of an adhesive fluid at a defined pressure from the inside to the outside of the balloon) to secure the clot to the mesh membrane for removal from a vessel by the removal catheter (as taught by Herbert; Figs. 1E-G, para. 0076).
Regarding claim 28, modified Keating discloses wherein the expandable mechanism 109 comprises a balloon (Fig. 1m para. 0041 of Keating).
Regarding claim 36, modified Keating discloses wherein the removal catheter comprises a second port 2 (Fig. 1, para. 0070 of Chhabra: “side holes (2) in the catheter walls”), the second port 2 being positioned on a different side of the removal catheter than the first port (see Fig. 1 of Chhabra which illustrates the ports 2 on opposing sides of the catheter).
Claims 3, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert] and Chhabra et al. (US 20060079923) [hereinafter Chhabra] as applied to claims 1 and 27 above, and further in view of Griffin (US 20050137622).
Regarding claims 3 and 29, modified Keating discloses all of the limitations set forth above in claims 1 and 27. However, modified Keating fails to disclose wherein the expandable mechanism comprises expandable tines.
Griffin in the same field of endeavor teaches a catheter comprising an expandable member 40 wherein the expandable member comprises expandable tines (interpreted as struts formed by cuts 80; Figs. 6-10, para. 0054, 0061) for the purpose of occluding vasculature (para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the expandable member in modified Keating for the expandable member comprising the expandable tines of Griffin, since such a substitution would yield the predictable result of occluding vasculature (para. 0049 of Griffin); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 30, modified Keating discloses wherein the plurality of expandable tines (interpreted as struts formed by cuts 80) comprises four expandable tines (Figs. 6-10, para. 0054, 0061 of Griffin).
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert] and Chhabra et al. (US 20060079923) [hereinafter Chhabra] as applied to claim 1 above, and further in view of Agrawal (US 20120271231).
Regarding claims 7 and 21, modified Keating discloses all of the limitations set forth above in claim 1. Modified Keating further discloses that the first catheter 105 and/or second catheter 121A can be aspiration catheters (para. 0049, 0061 of Keating). However, modified Keating fails to disclose a third catheter having a proximal end and a distal end and movable through a lumen of the first catheter, wherein the third catheter is an aspiration catheter.
Agrawal in the same field of endeavor teaches a thrombectomy system comprising a first thrombectomy catheter 20, a second occlusion catheter 40 disposed within the first catheter 20 (Fig. 1A, para. 0017), and a third aspiration catheter 60 having a proximal end and a distal end 63 and movable through a lumen 24 of the first catheter 20 (Fig. 1A, para. 0024).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of modified Keating to include a third catheter as the aspiration catheter instead of the first catheter, as taught by Agrawal (Fig. 1A, para. 0024), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert] and Chhabra et al. (US 20060079923) [hereinafter Chhabra] as applied to claim 1 above, and further in view of Courtney et al. (US 20020016564) [hereinafter Courtney].
Regarding claim 23, modified Keating discloses all of the limitations set forth above in claim 1. However, Modified Keating fails to disclose wherein the removal catheter is movable through a second lumen of the first catheter.
Courtney teaches a first balloon catheter 102 (Fig. 3D) comprising an inner catheter movable through a first lumen 166 of the first catheter 102 and a treatment device 130 moveable through a second lumen 168 of the first catheter 102 (Fig. 3D, para. 0038, 0043), as a known alternative to the first catheter comprising only one lumen for delivery two devices (see Figs. 3A-B, para. 0041).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first catheter of modified Keating to include two device delivery lumens, as taught by Courtney, since Courtney expressly disclose that the dual lumen catheter is a known alternative to the single lumen catheter. The substitution for one catheter configuration for another would yield the predictable result of a way to deliver multiple instruments through the first catheter (para. 0043 of Courtney); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 25, modified Keating discloses further comprising a reservoir (interpreted as the syringe described in para. 0048 of Chhabra) including the adhesive in fluid communication with a lumen of the removal catheter (para. 0048 of Chhabra: “A calculated volume of radiopaque/cyanoacrylate formulation, the sealing adhesive fluid material, is injected into the catheter and is chased with saline up into the balloon using a syringe equipped with a pressure gauge”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Chhabra et al. (US 20060079923) [hereinafter Chhabra] and Courtney et al. (US 20020016564) [hereinafter Courtney] as applied to claim 25 above, and further in view of Teitelbaum (US 20160158500).
Regarding claim 26, modified Keating discloses all of the limitations set forth above in claim 25. However, modified Keating fails to disclose wherein the adhesive is comprised of N-butyl cyanoacrylate.
Teitelbaum teaches an anchor stent 50 that may be employed endovascularly and used for a variety of medical procedures such as stroke thrombectomy (para. 0013), the device 50 may also be used to infuse therapeutic particles and/or substances to a target site such as an adhesive comprising N-butyl cyanoacrylate (Fig. 5, para. 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive in modified Keating to include the adhesive comprising N-butyl cyanoacrylate of Teitelbaum (para. 0027 of Teitelbaum) since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use (In re Leshin 125 USPQ 416; MPEP 2144.07).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Chhabra et al. (US 20060079923) [hereinafter Chhabra], and Hesselbjerg (US 20180071483).
Regarding claim 33, Keating discloses a system 100 for removing a clot from a vessel (Fig. 1, para. 0041) comprising:
a first delivery means (interpreted as balloon guide catheter 105) having a first proximal end (not shown), a first distal end 111 (Fig. 1, para. 0041), and a first lumen 117 therebetween (Fig. 1, para. 0041);
a proximal inflation means (interpreted as proximal balloon 113) disposed at a first distal portion of the first catheter 105 (Fig. 1, para. 0041);
a second delivery means (interpreted as inner tube 121) having a second proximal end (not shown), a second distal end 107 (Fig. 1, para. 0041), and an outer diameter less than an inner diameter of the first lumen 117 of the first delivery means 105 (best shown in Fig. 1, para. 0041: “The balloon guide catheter 105 can further include the device delivery lumen 117 that extends through the balloon guide catheter 105 and that can be sized to allow the inner tube 121 to slide therethrough”);
an expandable means (interpreted as distal occlusion element 109) disposed at a second distal portion of the second delivery means 121 (Fig. 1, para. 0042);
a plaque displacement apparatus 123 comprising a removal catheter 126 including a distal tip 125 (Fig. 1, para. 0043, para. 0048: “the plaque displacement apparatus 123 can contact the plaque P within the walls of the blood vessel, such that portions (fragments) F of plaque become displaced”).
Keating further discloses that the plaque displacement apparatus 123 comprises expandable tines (see Fig. 1) and is used to cut against and fragment plaque (see Figs. 2D-E, para. 0048), wherein in a clot retention configuration, the plaque displacement apparatus 123123 is distal to the proximal inflation means 113 (see Figs. 2D-E) and wherein, in a clot removal configuration, the retention means 123 is proximal to the proximal inflation means 113 (Fig. 2I, para. 0056).
However, Keating fails to disclose a retention means that utilizes an adhesive to fracture plaque and retain clot in a vessel.
Herbert in the same field of endeavor teaches a clot retrieval device comprising a retention means (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073), wherein, in an expanded configuration (Figs. 1E-F), the balloon is expanded to engage with a clot (Figs. 1E-F, para. 0076), wherein, in a clot retention configuration, the balloon is distal to a catheter 10 and the clot is secured to balloon with an adhesive 243 disposed on an outer surface of the balloon (Figs. 1D-F, para. 0076), and wherein, in a clot removal configuration, the balloon is withdrawn and the clot is secured to the balloon with the adhesive (para. 0076).
The substitution of one known clot removal device (the retention means comprising the removal catheter and adhesive coated balloon as shown in Herbert) for another (the plaque displacement apparatus as shown in Keating) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the clot retention mechanism shown in Herbert would have yielded predictable results, namely, a way to engage and loosen clot material in its expanded state while also capturing the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert) which is beneficial to the intended purpose of Keatings device (para. 0040 of Keating: “Some examples presented herein can be used to isolate a lesion during plaque displacement such that plaque located on a blood vessel wall can be displaced and removed from the vasculature while inhibit dislodged plaque fragments from migrating from the treatment site”); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).However, modified Keating fails to disclose the removal catheter includes a port and a mesh membrane positioned around the port, a plurality of openings distributed throughout a majority of a surface area of the mesh membrane; and wherein, in an inflated configuration, the mesh membrane is expanded by the adhesive introduced through the port and at least a portion of the adhesive permeates the mesh membrane to engage with the clot with the adhesive.
Chhabra in the same field of endeavor of balloon catheters teaches that it is known in the art for balloon catheters to deliver adhesive through a lumen of the catheter and out of micropores of the balloon (para. 0019: “wherein the balloon is in fluid communication with at least one lumen defined within the catheter, wherein the balloon comprises a plurality of micropores, wherein the micropores in the balloon allow expression of an adhesive fluid at a defined pressure from the inside to the outside of the balloon). The balloon catheter comprises a port 2 and a mesh membrane 1 positioned around the port 2 (Fig. 1, para. 0070: “FIG. 1 illustrates a balloon (1), side holes (2) in the catheter walls for extruding and expressing a sealing adhesive fluid material into the lumen of the balloon”), wherein the mesh membrane 1 comprises a plurality of openings 7 (Fig. 3, para. 0076), wherein the plurality of openings 7 distributed throughout a majority of a surface area of the mesh membrane (para. 0067: “The pores may be disposed over the entire surface of the balloon (about 100% coverage”); and wherein, in an inflated configuration, the mesh membrane is expanded by an adhesive introduced through the port and at least a portion of the adhesive permeates the mesh membrane to engage with a target site (see citation of para. 0019 above; para. 0046: “the balloon may be inflated with a bio-adhesive fluid”).
Accordingly, injecting adhesive through pores is a known alternative to coat the balloon with the adhesive for adhesive delivery. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive coated balloon and removal catheter in modified Keating to include the micropores, thereby forming the mesh membrane and port, respectively, as taught by Chhabra since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the mesh membrane used in Chhabra would also deliver the adhesive to the target site (para. 0070 of Chhabra); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination of modified Keating in view of Chhabra would result in a product wherein, in the clot retention configuration, the mesh membrane of Chhabra (Fig. 1, para. 0070: “FIG. 1 illustrates a balloon (1), side holes (2) in the catheter walls for extruding and expressing a sealing adhesive fluid material into the lumen of the balloon”) is secured to the clot with the adhesive (as taught by Herbert; Figs. 1E-G, para. 0076 of Herbert); and wherein, in a clot removal configuration, the clot is secured to the mesh membrane with the adhesive (as taught by Herbert; para. 0076 of Herbert).
However, modified Keating in view of Chhabra fails to disclose the mesh membrane positioned around the distal tip.
Hesselbjerg teaches a balloon catheter used for delivering therapeutic fluid to a target site (Figs. 1-2, para. 0008, 0088) comprising a balloon 6 positioned around a distal tip 5 of a catheter 2 (para. 0088) as a known alternative to a balloon arranged on a catheter such that the distal tip of the catheter extends beyond the balloon (para. 0088).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the mesh membrane and catheter arrangement of the retention means in modified Keating such that the mesh membrane is positioned around the distal tip of the removal catheter, as taught by Hesselbjerg, since Hesselbjerg expressly teaches that the arrangements are known alternatives of each other (para. 0088 of Hesselbjerg) and the modification is a substitution for one known balloon arrangement for another. The substitution would yield the predictable result of an alternative way to construct a balloon catheter; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 34, modified Keating discloses wherein the port 2 is positioned at a distal end of the removal catheter 1 (see Fig. 1 of Chhabra, para. 0070; Note: the position of the port 2 on the distal end of the removal catheter of Chhabra is analogous to the position of the port 227 in the instant application, see Fig. 5, para. 0048 of the instant application).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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